1Department of Regulatory Affairs, Vijaya Institute of Pharmaceutical Sciences for Women, Enikepadu, Vijayawada, Andhra Pradesh, India-521108
2Department of Pharmaceutics, Vijaya Institute of Pharmaceutical Sciences for Women, Enikepadu, Vijayawada, Andhra Pradesh, India-521108
*Corresponding author. E-mail address: vinuthnarallapalli2211@gmail.com (Vinuthna. R)
The current study will offer an extensive comparison of drug marketing authorization systems within the European Union (EU) and Canada. It examines and compares the regulations, submission procedures, the availability of scientific advice, the type of review, the approving authorities, and the post-review requirements followed in Health Canada and the European Medicines Agency (EMA). Even though both territories adhere to ICH conventions and require CTD/eCTD formats, there are essential distinctions between accelerated approval programs, including Canada Priority Review and Notice of Compliance with Conditions (NOC/c), and the EU Accelerated Assessment, Conditional Approval, and PRIME programs. An overall comparison of procedures is in the form of a table showing differences in structure. In order to evaluate the real-life implementation, three case studies with the most common diseases, Keytruda (oncology), Spinraza (orphan/rare disease), and Humira biosimilar (biologic), were chosen, comparing regulatory approaches and approval dates. The results can be confirmed with the tables and graphs to prove the trends in the approval timelines. It can be concluded that Canada had earlier access to the oncology treatment given in advance through Priority Review, as happened with Keytruda, and the EU was ahead in approval of orphan and biosimilar drugs, having Spinraza and Humira as their representatives. What is captured by these trends is the various strategic focuses and maturity of the regulatory systems. A further analysis of their differences and resulting regulatory planning, when to submit, and the commercial launch of products is also discussed. The insights can help pharmaceutical companies customize region-specific regulatory approaches on the basis of the type of drug and therapeutic area. The recommendation at the end is the adaptability and cross-regional knowledge in the regulations to allow more efficient access for patients to innovative therapies.
This review article eventually offers a useful guide to interested parties in terms of international drug development, regulatory relations, and market access strategy.
Marketing Authorization, Health Canada, European Medicines Agency (EMA), PRIME programs, Notice of Compliance (NOC), CHMP, CTD/eCTD
